Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36440 |
| Brand Name: | ShockPulse Lithotripsy System |
| Model: | ShockPulse-SE Lithotripsy System – Reusable Probes and ShockPulse Lithotripsy Generator |
| Affected: | Serial number - CG6069 |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Gyrus ACMI Inc |
| Issue: | The manufacturer has identified through an internal investigation that specific serial numbers of ShockPulse generators may have a mis-wired component. This condition does not impact the intended functionality of the device; however, the miswiring may introduce additional electrical noise on the power supply output. The presence of noise on the ultrasonic input circuit is not compliant with applicable electromagnetic compatibility (EMC) standards and may adversely affect the overall reliability of the system. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/1/2026 |
